Twice weekly pulse and daily continuous dose erlotinib as initial treatment for patients with EGFR-mutant lung cancers and brain metastases

摘要: BackgroundIn a phase 1 study of pulse-continuous dose erlotinib, no patient had disease progression in the central nervous system. This expansion cohort of the phase 1 study tests this same regimen in a cohort of individuals with EGFR-mutant lung cancers with untreated brain metastases.MethodsPatients had not received epidermal growth factor receptor (EGFR) TKIs or radiation for brain metastases. All received of erlotinib 1200 mg on days 1&2 and 50 mg on days 3–7 weekly. The primary endpoints were overall and central nervous system (CNS) response rates by RECIST 1.1 and progression free survival.ResultsBetween May 2015 to August 2016, we enrolled 19 patients. 42% of patients had target brain lesions and the median size of target brain lesions was 13 mm. Overall, 14 patients (74%, 95% confidence interval (CI) 51 to 89%) had partial responses. The response rate in brain metastases was 75 …